A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions and Subcutaneous Injections of ABBV-519 in Adult Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)

NCT07607964 · tracked via the Priya Life Science Japan tracker

Sponsor

AbbVie

Phase

Phase 1

Started

2026-05-28

Last updated

2026-10-15

Condition(s) studied

Systemic Lupus ErythematosusRheumatoid Arthritis

Investigational drug(s) / intervention(s)

ABBV-519ABBV-519

ABBV-519: Intravenous (IV) Infusion

ABBV-519: Subcutaneous (SC) Injection

Study summary

Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity.

Rheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety of ABBV-519 in adult participants with SLE or RA.

This is a single ascending dose study in an estimated 30 adult participants with moderate SLE or RA. The total duration of the study will be approximately 425 days (60-day Screening Period, 1-day Treatment Period, and a 52 week Follow-up Period) at approximately 15 to 20 sites globally.

There may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Eligibility

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

Inclusion Criteria: Key Inclusion Criteria: * Individuals between 18 and 75 years of age inclusive at the time of Screening. * Minimum baseline B-cell count of 50 cells/mcL. Inclusion Criteria for SLE Participants: * Clinical diagnosis of SLE and fulfilling the 2019 EULAR/ACR classification criteria. * Positive ANA ≥ 1:80 and the presence of at least one of the following autoantibodies above the upper limit of normal (ULN): anti-double-stranded DNA (dsDNA), anti-Smith (Sm), anti-ribonucleoprotein (RNP), or anti-Sjogren's syndrome antigen A (SSA). * Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score of ≥ 4 (excluding anti-dsDNA and C3/C4). Lupus headache or organic brain syndrome do not count towards the hSLEDAI points required for eligibility. * Participants must have an inadequate response to ≥ 1 immunosuppressant therapies, used for at least 3 months. Inclusion Criteria for RA Participants: * Clinical diagnosis of RA and fulfilling the 2010 ACR/EULAR classification criteria for RA. * Presence of rheumatoid factor (RF) or anti-citrullinated peptide antibodies (ACPA) above the ULN. * Presence of at least 6 swollen and 6 tender joints * High-sensitivity C-reactive protein (hs-CRP) ≥ 3 mg/L. * Failed at least 1 conventional synthetic disease-modifying antirheumatic drug (DMARD) and ≥ 1 biological or targeted DMARDs of different classes. Exclusion Criteria: Key Exclusion Criteria: * Participants with a history of infection. * Participants with uncontrolled hypertension Exclusion for SLE Participants: * Active neuropsychiatric SLE, or signs or symptoms of neuropsychiatric SLE within the 6 months prior to Screening (lupus headache permissible). \- Unstable or progressive glomerulonephritis (active class III or IV). * SLE overlap syndromes including, but not limited to RA, Sjogren's disease (SjD), SSc, polymyositis, dermatomyositis, or mixed connective tissue disease. Exclusion for RA Participants: \-- History of RA overlap syndromes, including but not limited to SLE, SjD, scleroderma, mixed connective tissue disorder or polymyositis.

Primary outcome measure(s)

Change from Baseline in B Cells in Blood — Up to 365 Days
Change from baseline in B cells in blood.
Maximum Plasma Concentration (Cmax) of ABBV-519. — Up to 85 Days
Cmax of ABBV-519
Time to Cmax (Tmax) of ABBV-519 — Up to 85 Days
Tmax of ABBV-519
Terminal Phase Elimination Half-Life (t1/2) of ABBV-519 — Up to 85 Days
t1/2 of ABBV-519
Area Under the Concentration-Time Curve From Time 0 to Last Measurable Concentration (AUCt) of ABBV-519 — Up to 85 Days
AUCt of ABBV-519
Percentage of Participants with Detection of Anti-Drug Antibodies (ADAs) for ABBV-519 — Up to 169 Days
Percentage of participants with detection of ADAs for ABBV-519
Number of Participants with Adverse Events (AEs) — Up to 425 Days
An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Trial sites (14)

Facility	City	Region	Status
Pinnacle Research Group /ID# 278677	Anniston	Alabama	Recruiting
Solace Research /ID# 279155	Tustin	California	Recruiting
Clinical Research Of West Florida - Phase I Unit /ID# 279292	Clearwater	Florida	Recruiting
Finlay Medical Research - Greenacres /ID# 278380	Greenacres City	Florida	Recruiting
Clinical Research of Osceola /ID# 278374	Kissimmee	Florida	Recruiting
Allied Biomedical Research Institute /ID# 284408	Miami	Florida	Recruiting
Discovery Health Research Center /ID# 279691	Plantation	Florida	Recruiting
Clinical Research Of West Florida - Tampa - North Howard Avenue /ID# 279130	Tampa	Florida	Recruiting
Advanced Quality Medical Research /ID# 279147	Orland Park	Illinois	Recruiting
West Tennessee Research Institute - Jackson /ID# 284561	Jackson	Tennessee	Recruiting
Epic Medical Research /ID# 279180	Red Oak	Texas	Recruiting
Japan Community Healthcare Organization Chukyo Hospital /ID# 279611	Nagoya	Aichi-ken	Recruiting
Institute of Science Tokyo Hospital /ID# 279648	Bunkyo-ku	Tokyo	Recruiting
National Center for Global Health and Medicine /ID# 281191	Shinjuku-ku	Tokyo	Recruiting

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Other trials for the same condition

Phase 3 Extension Study to Evaluate Long-term Safety of Ianalumab in Participants With Systemic Lupus Erythematosus (SIRIUS-SLE Extension). Recruiting

Phase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1) Active, not recruiting

ROSA Knee Intraoperative Planning Flexibility Study Recruiting

A Study of Obexelimab in Patients With Systemic Lupus Erythematosus Active, not recruiting

A Study of E6742 in Participants With Systemic Lupus Erythematosus Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07607964 on ClinicalTrials.gov ↗ ← All trials in Japan